Nadcap-like Program Holds Promise for Recall Reduction and Enhanced Quality Assurance for Medtech Industry

Courtney A. Stevens, Esq. | Senior Attorney, Medmarc Loss Control

The Performance Research Insitute (PRI), the not-for-profit organization responsible for spearheading the Nadcap program in the aerospace industry, is now turning its focus on medtech and hoping to have the same dramatic results in quality improvement and supply chain management there that is attributed to it for aerospace.

Despite the multitude of standards and regulations that medical device and component part manufacturers are subject to, and indeed the corresponding barrage of audits to which they are subjected, leaders in the medical device industry working with PRI identified a real gap left by all—critical processes. That is, the specific, crucial processes manufacturers use to create their products—heat treating, welding, sterilization, plastics molding, printed circuit board assemblies, cable and wire harness, etc.—are not the focus of quality management system audits. Suppliers can pass all audits imposed on them by the FDA and their OEM-customers without ever having the integrity of their critical manufacturing processes assessed by subject matter experts. PRI’s MedAccred program endeavors to change that, and has already been adopted by some of the largest medical device OEMs (original equipment manufacturer) in the industry, including Johnson & Johnson, Stryker, and Philips Healthcare.

This article, Bringing Nadcap to the Medical Industry, discusses the prospects for the program in greater detail.